The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Additional Ims Assays For The Bayer Advia Ims System.
| Device ID | K991907 |
| 510k Number | K991907 |
| Device Name: | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca, Jr |
| Correspondent | Gabriel J Muraca, Jr BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CZW |
| Subsequent Product Code | CFQ |
| Subsequent Product Code | DBI |
| Subsequent Product Code | DDG |
| Subsequent Product Code | KTO |
| Subsequent Product Code | LEG |
| Subsequent Product Code | LEH |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-07 |
| Decision Date | 1999-11-09 |
| Summary: | summary |